Eli Lilly and Merck & Co. said today they will team up on a Phase I study that will assess the immuno-oncology combination of Lilly's cyclin-dependent kinase (CDK) 4 and 6 inhibitor abemaciclib (LY2835219) with Merck's marketed cancer therapy Keytruda® (pembrolizumab) across multiple tumor types.

Based on the Phase I trial results, the collaboration could progress to Phase II trials in patients diagnosed with either metastatic breast cancer or non-small cell lung cancer (NSCLC), Lilly and Merck said.

Lilly will sponsor the Phase I study and any subsequent Phase II studies. Enrollment is set to begin in early 2016.

The collaboration is not the first for Lilly and Merck. Back in January, the companies launched a collaboration to study Keytruda in separate combinations with Lilly compounds in clinical trials, including a Phase II study with pemetrexed in first-line non-squamous, non-small cell lung cancer (NSCLC); a Phase I/II study with ramucirumab with pembrolizumab in multiple tumors; and a Phase I/II study with necitumumab in NSCLC.

“We're encouraged by our productive immuno-oncology collaborations with Merck, through its affiliates, and coming together for another clinical trial is a natural evolution of our scientific collaboration,” Richard Gaynor, M.D., svp, product development and medical affairs for Lilly Oncology, said in a statement.

Abemaciclib is a cell cycle inhibitor that is designed to block the growth of cancer cells by specifically inhibiting CDK4 and CDK6. Abemaciclib is in Phase III development with two trials in HR+ breast cancer patients, as well as a Phase III trial in lung cancer.

“With our active Phase III program underway for abemaciclib in both metastatic breast cancer and non-small cell lung cancer, we are committed to uncovering every opportunity to help these patients—and this includes exploring abemaciclib in combination with immunotherapy,” Dr. Gaynor added.

Keytruda is a humanized monoclonal antibody that works by blocking interaction between the programmed death receptor-1 (PD-1) and its receptor ligands, PD-L1 and PD-L2—thus increasing the immune system’s ability to fight cancer in cells that produce the pigment responsible for color in the skin.

Keytruda was the first PD-1 inhibitor allowed for use as a drug in the U.S. when approved by the FDA last year. Most recently, the drug made news when former president Jimmy Carter was declared free of cancer after using the drug plus radiation therapy to treat his metastasized melanoma.








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